Intensified Pharmacological Treatment for Schizophrenia, Major Depressive Disorder and Bipolar Depression After a First-time Treatment Failure (INTENSIFY)
This randomized, controlled trial (n=1254) investigates the effect of an intensified pharmacological treatment (including ketamine/esketamine and clozapine) for schizophrenia, major depressive disorder (MDD), and bipolar depression in subjects who experienced a first-time treatment failure on their first-line treatment.
Details
INTENSIFY is an international, multicentre, randomised, open-label (assessors blinded) parallel-group trial comparing early-intensified pharmacological treatment versus treatment as usual across schizophrenia, major depressive disorder and bipolar depression samples.
Primary outcome is change in symptom severity from baseline to end of treatment (PANSS for schizophrenia; MADRS for MDD and BD). Secondary outcomes include CGI, HADS, cognitive tests, quality of life/functioning measures, side-effect burden, concomitant medication use and discontinuation rates.
Interventions mirror clinical practice per SmPC: SZ EIPT uses clozapine; MDD EIPT uses second-line antidepressant plus esketamine nasal spray or (es)ketamine/ketamine infusion; BD EIPT uses an antidepressant plus two mood stabilisers (lithium, valproate, quetiapine).